EMS PEEP VALVES- ADJUSTABLE

K983920 · Engineered Medical Systems · BYE · Jan 22, 1999 · Anesthesiology

Device Facts

• Record ID: K983920
• Device Name: EMS PEEP VALVES- ADJUSTABLE
• Applicant: Engineered Medical Systems
• Product Code: BYE · Anesthesiology
• Decision Date: Jan 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitator, therapeutic CPAP systems, ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H2O

Device Story

EMS Adjustable PEEP Valve is a spring-actuated mechanical valve placed in breathing circuits to provide positive end expiratory pressure (0-20 cm H2O). Used with manual resuscitators, therapeutic CPAP systems, and ventilators; intended for single-patient use in hospital or emergency settings. Device functions by applying spring-actuated tension to regulate expiratory pressure, assisting clinicians in maintaining airway pressure. Benefits include adjustable pressure settings to meet specific patient respiratory needs.

Clinical Evidence

No clinical data. Bench testing only; comparison of design, materials, and performance specifications against predicate devices.

Technological Characteristics

Spring-actuated mechanical valve; adjustable pressure range 0-20 cm H2O. Materials: polycarbonate, K-resin, propionate housing; stainless steel spring. Fittings: 19mm, 22mm, 30mm. Single-patient use. No software or electronic components.

Indications for Use

Indicated for patients requiring positive end expiratory pressure (PEEP) therapy via manual resuscitators, therapeutic CPAP systems, or ventilator circuits in hospital or emergency medical service settings.

Regulatory Classification

Identification

A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.

Predicate Devices

• EMS PEEP valve (K932799)
• Ambu PEEP (K923976)
• Intertech PEEP (K# unknown)

Submission Summary (Full Text)

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K983920

## Engineered Medical Systems

500LLE BOAD + NDIANAPOLIS, IN 46268 • [317] 872-5500 • FAX [phone]
Non-Confidential Summary of Safety and Effectiveness 8529 ZION

| | page 1 of 2 |
|-----------------------------------------------------------------------------------|---------------------------------------------------------|
| | November 2, 1998 |
| Engineered Medical Systems, Inc.<br>8529 Zionsville Rd.<br>Indianapolis, IN 46268 | Tel - [phone] |
| | Fax - [phone] |
| Official Contact: | Jeff Quinn - President |
| Proprietary or Trade Name: | EMS Adjustable PEEP Valve |
| Common/Usual Name: | PEEP valve |
| Classification Name: | Breathing attachment - positive end expiratory pressure |
| Device: | EMS PEEP Valve |
| Predicate Devices: | EMS PEEP valve - K932799 |
| | Ambu - PEEP - K923976 |
| | Intertech - PEEP - K# unknown |

Device Description:

The EMS PEEP valve is a adjustable valve which is placed in circuit and provides for positive end expiratory pressure for the patient. It is a spring actuated valve which adjusts from 0 to 20 cm H2O.

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| Indicated Use -- | Indicated as an accessory to provide positive end expiratory pressure<br>breathing capabilities to manual resuscitators, therapeutic CPAP systems<br>and ventilator circuits. |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use -- | Hospital, Emergency Services |

## Comparison to Predicate Devices: -

| Attribute | EMS<br>Adjustable | Ambu<br>K9323976 | Intertech<br>K# unknown |
|-------------------------------------------------------------|-------------------|------------------|-------------------------|
| Use | | | |
| Indicated for providing positive<br>end expiratory pressure | Yes | Yes | Yes |
| Used on manual resuscitators | Yes | Yes | Yes |

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## Non-Confidential Summary of Safety and Effectiveness

page 2 of 2

November 2, 1998

| Comparison to Predicate Devices: | | | |
|------------------------------------------|-------------------|---------------------------------|-------------------------|
| Attribute | EMS<br>Adjustable | Ambu<br>K9323976 | Intertech<br>K# unknown |
| Use | | | |
| Used with therapeutic CPAP systems | Yes | Yes | yes |
| Placed in the breathing circuit | Yes | Yes | Yes |
| Intended to be single patient | Yes | Yes | Yes |
| Environment Home, EMS | Yes | Yes | Yes |
| Design | | | |
| Adjustable pressure range<br>0-20 cm H₂O | Yes | Yes | Yes |
| Fitting 19, 22, 30 mm | Yes | Yes | Yes |
| Spring actuated tension | Yes | Yes | Yes |
| Materials | | | |
| Materials of housing | | | |
| Polycarbonate, K-resin, propionate | Yes | Yes - K-resin,<br>Polycarbonate | Yes |
| Spring - stainless steel | Yes | Yes | Yes |
| Performance Standards / Specifications | | | |
| None required under Section 514 | Yes | Yes | Yes |

Differences between Other Legally Marketed Predicate Devices . . . . . . . . . . . . . . . .

There are no significant differences between the intended device and the predicate - EMS PEEP valves -K932799, Ambu - K923976 and Intertech - K unknown.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 22 1999

Mr. Jeff Quinn President Engineered Medical Systems 8529 Zionsville Road Indianapolis, IN 46268

Re : K983920 PEEP valves Requlatory Class: II (two) Product Code: BYE Dated: November 2, 1998 Received: November 4, 1998

Dear Mr. Quinn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, ² Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

ATIONS FOR USE

| 510(k) Number: | K983920 (to be assigned) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | EMS PEEP Valves |
| Intended Use: | Indicated as an accessory to provide positive end expiratory pressure breathing capabilities to manual resuscitator, therapeutic CPAP systems, ventilator circuits. Available in 19mm, 22mm and 30 mm fittings. Pressure range from 0 to 20 cm H2O |
| Environment of use: | Hospital, Emergency Medical Services |

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)
✓

or

Over-the-counter use ___

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________